DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-8 are pending in the instant application. Claims 1-8 are rejected.
Information Disclosure Statements
The information disclosure statements filed on November 16, 2023 and December 17, 2025 have been considered and signed copies of form 1449 are enclosed herewith.
Drawings
The drawings are objected to because the chemical structures of the compounds S-HCQ and R-HCQ are difficult to see. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over US 2021/0369699 A1 in view of Nuri et al. (Immunologic Research, 65(1):17-24, 2017) and U.S. Patent No. 5,314,894.
US 2021/0369699 A1 discloses a method for treating lupus erythematosus by administering to a patient a pharmaceutical composition that contains S-hydroxychloroquine (S-HCQ) and a pharmaceutically acceptable excipient wherein the pharmaceutical composition is essentially free of R-hydroxychloroquine (R-HCQ) (see abstract). It is also disclosed in the reference that the S-hydroxychloroquine is in the form of a pharmaceutically acceptable salt wherein the pharmaceutically acceptable salt is a hydrochloride salt, a sulfate salt or a phosphate salt (see claims 2 and 3) and that a dose of the S-hydroxychloroquine administered to the subject is 100 mg to 800 mg per day, specifically 200 mg per day (see claims 4 and 5). Finally, it is disclosed that the pharmaceutical composition is in the form of granules, a tablet, a capsule, a pill, a powder, a solution, a suspension, or a syrup (see claim 12).
US 2021/0369699 A1 does not disclose a method for treating antiphospholipid (APS), however.
Nuri et al. discloses that long-term use of hydroxychloroquine reduces antiphospholipid antibodies levels in patients with primary antiphospholipid syndrome (see abstract).
Nuri et al. does not disclose the use of the specific isomer S-hydroxychloroquine (S-HCQ) nor does it disclose that the APS is a thrombotic or obstetric APS, however.
U.S. Patent No. 5,314,894 discloses using a composition containing (S)-(+)-hydroxychloroquine substantially free of (R)-(-)-hydroxychloroquine, or a pharmaceutically acceptable acid-addition salt thereof in a method of treating malaria, lupus erythematosus or rheumatoid arthritis (see abstract). The reference also discloses that there often are pharmacodynamic and pharmacokinetic differences between the two enantiomers in drugs which have an asymmetric center and that therapeutic efficacy may reside entirely or for the most part in one of the two enantiomers. Therefore, it would be desirable to administer the single enantiomer in which the therapeutic efficacy resides. See column 2.
US 5,314,894 does not disclose a method for treating antiphospholipid (APS), however.
Since all three references disclose using hydroxychloroquine in the treatment of an autoimmune disorder and it is well known in the art (e.g., like it is disclosed in US 5,314,894) that it could be desirable to administer a single enantiomer in which the therapeutic efficacy resides, it would have been obvious to one of ordinary skill in the art at the time of the invention through routine experimentation to carry out a method of treating APS using a composition containing (S)-(+)-hydroxychloroquine which is substantially free of (R)-(-)-hydroxychloroquine in view of the references and to arrive at a method of the instant claims with a reasonable expectation of success. The motivation would have been to find an optimal pharmaceutical for the treatment of APS. Thus, a prima facie case of obviousness has been established.
Conclusion
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/KRISTIN A VAJDA/Primary Examiner, Art Unit 1622